International regulatory news in brief

UK

6 March 2026

Guidance updated: MHRA phase I accreditation scheme

This guidance has been updated to add the latest List of Phase I accredited organisations/units

Source: MHRA

4 March 2026

Guidance updated: Medicines – get scientific advice from MHRA

In this guidance, the section on joint advice has been updated to reflect and link to the MHRA and NICE Integrated Scientific Advice service.

Source: MHRA

3 March 2026

Guidance updated: Early Access to Medicines Scheme: Overview

EAMS Submission dates updated to run until 2028.

Source: MHRA

2 March 2026

Guidance updated: MHRA Portal – register to submit forms

MHRA Portal registration form added and guidance updated.

25 February 2026

Guidance updated: Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing

This guidance has been updated page to add new information on responsibilities and reporting on nitrosamine impurities.

Source: MHRA

18 February 2026

Guidance updated: Clinical trials for medicines: apply for authorisation in the UK

According to the MHRA, this guidance has been updated as follows:

• The clinical trial definition section has been ‘clarified’ and outdated information has been deleted.
• Information under the heading Applicants must submit the following has been upfdated.

Source: MHRA

10 February 2026

Impact of the amended CIR 520/2012 to UK authorised products

From 12 February 2026, changes to an EU regulation (the Commission Implementing Regulation 520/2012) will come into effect.

• These changes relate to how the safety of medicines is monitored – known as pharmacovigilance.
• The EU updates will affect how some UK-authorised medicines need to meet safety monitoring requirements, especially where companies hold licences in both the UK and the EU.authorised medicines need to meet safetymonitoring requirements, especially where companies hold licences in both the UK and the EU.
• To support companies or marketing authorisation holders, the MHRA has published a blog post and guidance explaining when to follow the amended EU rules and when to follow UK legislation.
• This impacts the Windsor framework.

Sources: MHRA, Linked In

21 January 2026

Guidance updated: Innovative Licensing and Access Pathway (ILAP)

The MHRA has posted the following updates with regard to the above pathway:

i) Wording added to eligibility criterion 4 and selection criteria assessment to bring additional clarity.

ii) Application open and close dates updated.

iii) Application Form for Innovation Passport application updated.

iv) Innovation Passport Round closing and opening dates updated for 2026.

v) ILAP application guidance updated

vi) In the “What’s on offer in the ILAP” section, minor editorial changes were made to the text to ensure clarity and additional contact information has also been added at the bottom of the page. The services on offer in the ILAP remain the same.

Source: MHRA

Guidance updated: International Recognition Procedure

Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance have been added. You can view the dates on this page.

A blog post on the procedure is available here.

Source: MHRA

20 January 2026

Guidance updated: Medicines – apply for a variation to your marketing authorisation

This guidance has been updated to add a substantial new section on Type II variations titled Variations to add a new therapeutic indication. Click on the link below to read the full text.

These variations will usually be classed as “Type II extended complex” because of the nature and extent of the supporting clinical data required to verify the safety and efficacy of the product in the proposed new indication and demonstrate that the balance of benefit and risk is positive. 

Source: MHRA

13 January 2026

The UK is ramping up efforts to become a global first choice for clinical trials, as new figures published today, show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – that will help companies get studies up and running more quickly, so patients can benefit from new treatments sooner.

• MHRA data shows clinical trial applications received rose by 9% between January and November 2025 compared with the same period in 2024.
• Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest. 
  • trials involving healthy volunteers – often the first step in testing whether a new medicine is safe – increased by 16%, alongside
  • rises in trials testing treatments in people for the first time (5%), and
  • those being run in the UK for the first time (7%), a sign of growing international confidence in the UK as a place to launch new research
• Companies are also coming to regulators earlier for help. The number of MHRA scientific advice meetings provided on clinical trials rose by 75% over that period, as developers seek to design trials right first time and avoid costly delays later on. 
• A package of significant changes will be delivered with new clinical trial regulations due to take effect from April 2026.
•  Under the new rules, around 1 in 5 studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies.
• The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research. 
• Alongside faster assessments, the new framework will support clearer, more agile routes to support innovation.
• This includes making better use of early safety data from overseas studies that meet UK standards, and new MHRA capability to assess computer model simulations, such as in-silico trials, to help predict how new medicines may behave before they are tested in patients.
• The aim is to reflect how modern medicines are developed today, without lowering safety standards. 
• Together, the reforms strengthen the UK’s offer to global life sciences developers as a safe, fast place to start high-quality clinical trials. They support the Government’s ambition to cut the time from trial application to first participant to 150 days.
• The reforms also align with wider Government action to modernise the research system through the 10 Year Health Plan for England. 

Source: MHRA

12 January 2026

Guidance updated: Common issues identified during clinical trial applications

This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.

The changes described below have been made to the guidance.

Edited ‘Common issues: Pharmaceutical’ publication.

• Clarified abbreviations.
• Added paragraphs on impurities and sterilisation and bioburden control.
• Amended re-test period and shelf-life sections.
• Re-arranged existing paragraphs.

You can view the updated document here.

Edited ‘Common issues: Non-Clinical’ publication

• Re-arranged existing paragraphs.
• Added sentence on justification of dose selection for first-in-human trials.
• Added paragraph on justification for choice of species. Added paragraph on photosafety.

You can view the updated document here.

Edited ‘Common issues: Clinical’ publication

• Re-arranged existing paragraphs.
• Clarified abbreviations.
• Updated legislation reference.
• Removed outdated link. 

You can view the updated document here.

Turkey

2 March 2026

The Guidelines on Import Applications and Market Placement Authorizations

The above guidelines have been updated and published.

• For applications submitted from March 2, 2026 onwards, the provisions of the Guidelines with revision number 6 will apply.
• Applications and documents required under the Guidelines on Import Applications and Market Release Authorizations must be addressed  to the Department of Economic Assessments and Pharmaceutical Supply Management .

Source: Titck

27 February 2026

Guidelines on Packaging Information and Instructions for Use of Human Medicinal and Guidelines on Excipients in Packaging Information and Instructions for Use of Human Medicinal Products

Both of the above guidelines have been updated and published.

Source: Titck

26 January 2026

Clinical Practice Guidelines

The “Clinical Practice Guidelines,” prepared to ensure access to regenerative medicine applications that can be performed with advanced therapeutic medical products, were published and entered into force on 23 January 2026. You can view/download them from this page.

Source: Titck

Switzerland

1 March 2026

Authorisation of biosimilars in Switzerland

Swissmedic is guided by the EMA Draft Reflection paper on a tailored clinical approach in biosimilar development as the state-of-the-art in science and technology and supports the main thrust of the paper.

• The EMA Draft Reflection paper on a tailored clinical approach in biosimilar development is expected to be finalised in mid 2026.
• Swissmedic agrees with the scientific and regulatory considerations outlined in the Reflection Paper and is already applying these principles.
• Currently, Swissmedic accepts new authorisation applications for biosimilars with authorisation documentation that does not include data on comparative efficacy studies (CES). justification for this should be provided in the cover letter and all available Scientific Advices from the EMA and the US FDA should be included with the application.
• As soon as the final version of the EMA Reflection Paper is issued, Swissmedic will adapt its Guidance document Authorisation Biosimilar accordingly.
• The document “Questions and answers on the authorisation of biosimilars” has already been updated and can be viewed here.

Source: Swissmedic

Changes to the Guidance document Authorisation human medicinal product under Art. 13 TPA

Swissmedic has revised the Guidance document Authorisation human medicinal product under Art. 13 TPA, and in addition to editorial changes, the wording has been made more precise in various sections.

• The changes made do not constitute changes to application requirements under Art. 13 TPA.
• The form Information for application Art. 13 TPA HMP has also been made more precise in the same sections as in the Guidance document.
• The revised Guidance document Authorisation human medicinal product under Art. 13 TPA and the form Information for application Art. 13 TPA HMP come into effect from 1 March 2026.

Source: Swissmedic

Requirements for the authorisation of inhaled and topical preparations with known active substances in the indications asthma and/or chronic obstructive pulmonary disease

As part of Swissmedic’s continuous efforts to adapt regulatory requirements to current scientific knowledge and harmonise them internationally, the Position on requirements for the authorisation of orally inhaled products (OIP) with known active substances for the treatment of asthma and/or chronic obstructive pulmonary disease (COPD) has been revised.

• Swissmedic has continually monitored the latest scientific findings and the requirements of other medicinal product authorisation agencies.
• Experience with the use of OIP with known active substances in countries that authorise such products on the basis of their pharmacokinetic (PK) data has not raised any relevant efficacy or safety concerns.
• The requirements for authorisation of inhaled and topical preparations containing known active substances in the indications asthma and/or chronic COPD have been revised on this basis.
• As a result of this revision, Swissmedic will now also accept PK data as the primary basis for demonstrating equivalence between OIP with known active substances and their reference products.
• A stepwise procedure for demonstrating equivalence between OIP with known active substances and their reference products is retained.
• This updated Position takes immediate effect and applies to all new applications for authorisation of OIP with known active substances for the treatment of asthma and/or COPD.

Source: Swissmedic

Adaptation of the guidance of drug information for medicinal products for human use

Swissmedic has fundamentally revised the chapter on undesirable effects.

• In particular, the procedure for the pooling of safety data has been specified.
• The route also provides a table format for the frequency data of undesirable effects.
• In the chapter Interactions of the specialist information, the detail depth of the requirements has been reduced.
  • The focus is on clinically relevant information.
  • In in vivo studies, only the ratio of pharmacokinetic parameters is required; negative in vivo or in vitro data are to be recorded only briefly.
  • Table formats are only provided in complex issues.
  • In addition, relevant in silico data can now also be used to describe the interaction potential.
  • Furthermore, drug interactions should also be listed as contraindications in the technical information, if applicable.
• The general requirements for the preparation of the technical information were combined in an introductory chapter.
• Swissmedic also holds its many years of practice in which various dosage forms can only be presented in a collective text if the joint presentation does not address any security concerns (such as possible application errors).
• In order to protect the environment, the Preclinical Data chapter now includes a reference to ecotoxicological studies for medicinal products with corresponding potential.
• In addition, the route guidance now provides guidance on professional disposal in the chapter Other Information, which can be voluntarily included in the specialist information.
• In the patient information, the recently received disposal notice is extended and adapted accordingly.
• For oncologics with genotoxic potential, a reference has been added that the Swiss guidelines are based on the FDA-published guideline for assessing the risk of reproductive toxic effects.
• In the section on clinical efficacy, information on immunogenicity was included, in particular on the effects of anti-drug antibodies on the efficacy of the drug.
• Various editorial adjustments were also made during the revision.

The adapted route guidance of medicinal products for human use applies to new drug information to be prepared from 1 March 2026.

• For applications for new registrations that are already in progress, applicants can voluntarily take into account the adapted guidance.
• This must be explicitly specified in the cover letter and can lead to an extended duration of the procedure in individual cases.
• For medicinal products already authorised, it is decided in justified cases in the context of requests for changes whether an adaptation of the medicinal product information in the chapters concerned is appropriate.

Source: Swissmedic

1 February 2026

Updating of Annex 7 TPLRO – Revised list of variations

The lists published by Swissmedic, incl. Annex 7 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22) have been revised and amended.

• A need for revision, particularly of Annex 7 TPLRO, was identified on the basis of the collected reports and in keeping with the requirements and specifications of EU legislation.
• This annex has been harmonised as far as possible with the EU list of variations.
• The form Variations and extensions HMP has also been amended accordingly on this basis.

The guidance document Guidance document Variations and extensions HAM has also been updated.

Source: Swissmedic

Changes to the Guidance document Drug Safety Signals HMP and the Signal Notification Form

The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements.

You can view the changes on this page.

7 January 2026

Scientific GMDP Meetings

Swissmedic offers companies that hold, or are in the process of applying for, a Swissmedic establishment licence, the opportunity to discuss project-specific questions related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) within the framework of a Scientific GMDP Meeting.

• The aim of these meetings is to clarify regulatory requirements and expectations at an early stage in connection with planned projects, extensions or amendments to establishment licences.
• This approach supports consistent implementation of legal requirements and facilitates efficient execution of projects.
• Scientific GMDP Meetings can be requested using the application form.
• A guidance document on the process provides detailed information on the prerequisites, procedure and required documentation.
• In addition, a meeting minutes form is available to support the preparation and documentation of the meeting.

Source: Swissmedic

6 January 2026

Updating of Annex 7 TPLRO – Revised list of variations

The lists published by Swissmedic, incl. Annex 7 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22) have been revised and amended.

• A need for revision, particularly of Annex 7 TPLRO, was identified on the basis of the collected reports and in keeping with the requirements and specifications of EU legislation.
• This annex has been harmonised as far as possible with the EU list of variations.
• The form Variations and extensions HMP has been amended accordingly on this basis.
• While the form comes into force on 1 February 2026, it can be viewed now via this link.
• Up until 31 January 2026, variations and extensions for human medicinal products must be submitted using the existing form (valid until 31 January 2026) and, from 1 February, using the new form (valid from 1 February 2026).

Source: Swissmedic